Publication SMART Trial - Odeyemi YE, Crit Care (2022) (published paper)
Dates: 2020-03-01 to 2020-11-30
Funding: Public/non profit (The American Heart Association COVID-19 Rapid Response Grant. The Mayo Clinic Critical Care Independent Multidisciplinary Program (IMP) Research Grant (Institutional Departmental grant). National Center for Advancing Translational Science (NCATS). National Heart, Lung, and Blood Institute)
Conflict of interest: No
Blinding: single blinding
Single center / USA |
Follow-up duration (days): 90
0.5 to 1.5 mg/kg methylprednisolone (or dose equivalent of oral prednisone) adjusted to daily CRP level.
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=4 / Moderate: n=25 / Severe: n=14 Critical: n=2
Number of vaccinated participants: NR
|In the register|
Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing [ Time Frame: Within 30 days of enrollment in study. ] Number of eligible subjects to adhered to the timely initiation and daily corticosteroid treatment according to ESICM/Society of Critical Care Medicine SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)
|In the report|
feasibility of the trial protocol
Yes. In English
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to the published article, the registry, protocol and statistical analysis plan were used in data extraction and assessment of risk of bias. This pilot trial was originally planned and registered in early 2019 to investigate biomarker-guided corticosteroid use in pneumonia and acute hypoxemic respiratory failure. A separate COVID-19 arm was added in 2020. There was a change to standard care due to the results of the RECOVERY trial. The primary feasibility outcome in the article reflects that in the registry and all planned outcomes are reported in the registry.
Results were also posted on the trial registry but data from direct contact with authors was given priority.
This study was updated on April 28th, 2022 with data acquired after contact with authors.